If you wish to market your nutraceutical products, dietary supplements and herbal products in Australian market, it will be better to realize that the Australian regulatory requirements are quite different from other countries for such products.
For example, in the United States of America (USA), such product can reach the pharmacy store, supermarket and retail stores just by filing the GRAS status (Generally Recognized As Safe)… along with, of course, some basic documentation. But, it’s a lot easier there.
On the other hand, Therapeutic Goods Administration (TGA) undertakes a thorough evaluation of safety, efficacy and quality of the product before it reaches the Australian market and consumers.
While, other countries may classify these products as
- nutritional supplements,
- homoeopathic medicines,
- traditional medicines,
- Ayurvedic medicines, or
- aromatherapy, in case of certain other products
but, not Australia!
For Australian agency, TGA, the name is medicines, “Complementary Medicines”.
So, what is the process for registering complementary medicines?
How to register nutraceutical product, dietary supplement or herbal products in Australia?
First, let’s understand how complementary medicines are defined by TGA.
What are Complementary Medicines?
As per TGA, Complementary Medicine means a therapeutic good consisting wholly or principally of one or more designated active ingredients, each of which has a clearly established identity and a traditional use.
Salient points to consider are as follows.
- Complementary Medicines are regulated as medicines under the Therapeutic Goods Act (1989)
- These are generally available for use in self-medication by consumers.
- Majority of complementary medicines are indicated for the relief of symptoms of minor, self-limiting conditions. Many are indicated for maintaining health and well being, or the promotion or enhancement of health.
Australian regulatory body, TGA has developed the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) to assist sponsors of complementary medicines to meet their legislative obligations.
One can obtain detailed information by visiting TGA website. https://www.tga.gov.au/complementary-medicines
Regulatory aspects for filing Complementary medicine
- All complementary medicines needs to be either listed or registered on the Australian Register of Therapeutic Goods (ARTG)
- ARTG is a database that includes details of all therapeutic goods that are imported into, supplied in, or exported from Australia.
- Each therapeutic good which gets included in ARTG, gets an AUST number based on the risk associated with it. All marketed product must contain the AUST number on their product label along with sponsor name and address.
- It is a legal requirement that, unless exempted or excluded, all therapeutic goods are included on the ARTG prior to their Supply to the consumer.
- An applicant seeking registration of complementary medicine is required to submit a detailed dossier of information to the TGA for evaluation. This data must establish that the proposed medicine is of appropriate quality, safety and efficacy before it is approved for inclusion on the ARTG.
TGA Classification for Complementary medicines
Complementary medicines may either be
- listed or
depending on their ingredients and the therapeutic claims made for the product.
The therapeutic claims must be backed up by suitable evidence. The stronger the claims made, the stronger the evidence must be.
Australian TGA adapts risk based approach for regulating their medicines review.
Low risk products are managed as ‘Listed Medicines’ compared to high risk products which needs to be evaluated and marked as ‘Registered Medicines’.
Let us understand what parameters are monitored by TGA for listed and registered medicines through this table below.
1. Listed Medicines
- Listed medicines are considered ‘low risk’ medicines.
- It contain certain low risk ingredients in acceptable amounts that are permitted for use in listed medicines by the TGA
- Product must be manufactured in accordance with the principles of Good Manufacturing Practice (GMP)
- Product must be used for indications (for therapeutic use) permitted for use in listed medicines
- The indications / claims on Listed medicines are not subject to pre-market evaluation. However at the time of Listing, the Act requires that, sponsors certify that they hold the evidence to support indications and claims and claims are true, valid and not misleading.
2. Assisted Listed medicines
- Medicines listed through the assessed listed medicines pathway will be included in the ARTG following self-certification of the safety and quality of the product.
- TGA performs pre-market assessment of efficacy to support the proposed indications.
3. Registered Medicines
- Registered complementary medicines are considered to be of relatively higher risk than listed medicines, based on their ingredients or the indications made for the medicine.
- Registered medicines are fully evaluated by the TGA for quality, safety and efficacy prior to being accepted on the Australian Register of Therapeutic Goods (ARTG) and able to be marketed.
Based on the product category decided by you, for your product submission to TGA, you have to prepare a comprehensive dossier for regulatory submission.
Are you planning to market your Complementary Medicine product in Australia?
Talk to us today. Provide preliminary details below and we will help you achieve a successful registration in Australia.
Credevo can be your strategic partner to make successful submission in timely manner.
You will get a complete overview on regulatory framework, process overview and timelines associated with submissions.
For preparing the dossier for TGA submission, one must consider 6 important aspects related to that. There are crucial requirements related to these sections that we have discussed in the part II of this series.